LONDON – This week’s announcement that the injection of AstraZeneca, the flagship of global vaccine launches, achieved nearly 80% effectiveness in an American gold standard test was welcomed with relief by many countries that depend on it.
“When you get the call, get the injection,” asked British health secretary Matt Hancock, as part of a campaign by European lawmakers to calm people’s nerves after a recent security scare with the gunshot.
But, on Tuesday, that campaign had once again been thrown off course, at least for now. For AstraZeneca, it was apparently yet another episode of public relations whiplash, part of a series of recent company errors and communication errors that scientists said had undermined the effort to sell people one of the most potent and indispensable coronavirus vaccines. .
In a highly unusual move, American health officials said on Tuesday that the company’s report on test results in the U.S. was not entirely accurate, suggesting that AstraZeneca used only the most favorable data to generate efficacy results. seemingly spectacular.
These comments created a new friction between AstraZeneca and the American authorities, even when the company disputes a coveted authorization from the Food and Drug Administration. But more urgently, they have affected the efforts of elected leaders around the world to rebuild confidence in an injection whose low price and easy storage requirements have made it the backbone of many countries’ campaigns to end the pandemic.
“It is undermining confidence,” said Simon Clarke, associate professor of cell microbiology at the University of Reading. “When you pump things up and people don’t question it unjustifiably, it erodes trust.”
Faith in the vaccine had already plummeted across Europe after recent reports that a very small number of recipients developed unusual blood clots.
In France, Germany, Italy and Spain, more people now believe that the vaccine is unsafe than safe, the poll showed, a blow to a shot that remains the continent’s best hope for saving people’s lives during the rise of new infections. Millions of doses are not used in refrigerators across the continent, with doctors reporting that some people canceled the injections for fear of side effects.
Despite the noise of worrying news about the vaccine, European and global regulators consider it safe and effective. More than 11 million doses have been administered in Britain alone, almost all without serious side effects, reducing hospitalizations and helping the country to emerge from a terrible wave of winter infections.
However, the AstraZeneca trial in the United States was long awaited. The largest of its kind for injection, it was expected to provide the clearest and most complete picture of the vaccine’s effectiveness. American officials saw this as an indisputable test of the vaccine’s performance.
And health officials around the world were looking at it as a crucial guide to their own launches: it would provide crucial data on older people, who had not been so well represented in previous tests, and a more accurate reading on the overall effectiveness of the vaccine, which appeared in previous tests to be inferior to that of other main photos.
As soon as AstraZeneca announced its results on Monday, saying the vaccine was 79 percent effective in preventing symptomatic Covid-19, lawmakers began citing it as part of their fledgling efforts to increase public confidence in the vaccine.
On Tuesday, the scientists said, it looked like AstraZeneca had opened a hole in those efforts. Instead of sewing questions about the photo, she recalled the communication problems that have plagued the company since last year, delaying the regulatory process in some regions and creating hesitations among some recipients.
So far, only 55 percent of AstraZeneca doses delivered to the European Union have been placed in people’s arms, according to the bloc’s figures, notably lower than the rate of use of other vaccines. About seven million doses are still in the refrigerators.
While some countries have administered more than 70% of their doses, others are struggling to get them off the shelves: Germany and France have given about half of their AstraZeneca supplies, and Luxembourg has administered only a third.
Scientists said that such a public disagreement between the American medical experts who oversaw a trial and the company that sponsored it was extremely unusual.
“It is usually done in private,” said Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, of any disagreements. “So, this is unprecedented, in my opinion.”
In its first public comments, AstraZeneca said the results published on Monday reflected data from its tests in the United States until February 17. She said her preliminary assessment of more complete test data showed that “the results were consistent with the interim analysis”, but said she would share more up-to-date efficacy results within 48 hours.
Scientists said the problem may still be a technical issue that has not changed his assessment of the vaccine. American officials have not suggested that any security issues have been overlooked, a subject of intense interest in the wake of concerns in Europe.
However, it quickly took the breath away from the candles of the European legislators’ public campaign to restore confidence in the shot, which was developed with the University of Oxford. In recent days, several political leaders, including Britain’s Prime Minister Boris Johnson and France’s Prime Minister Jean Castex, received the vaccine in an attempt to show people that it was safe.
“I literally felt nothing,” Johnson told reporters. “I can’t recommend it highly.”
The stumble on Tuesday was the latest in a series of mistakes that created a thorny relationship between AstraZeneca and American and European regulators – and, scientists said, created unnecessary public confusion about a vaccine that appears to be highly effective.
In early September, the company quietly suspended its global tests after a UK participant fell ill. But American regulators didn’t find out until the story was made public. Subsequently, the company’s slowness in providing the FDA with evidence that its vaccine was not linked to any disease kept it in the ground for nearly seven weeks. AstraZeneca said it shared data in a timely manner.
At the end of November, the company was on the rise again: it released the results of the first clinical trials, including in Great Britain, showing that the vaccine was 62% or 90% effective, depending on how the doses were administered.
But these results were also quickly overshadowed by uncertainty. AstraZeneca later acknowledged that there was initially confusion about the dosage of the vaccine received by some study participants, making it more difficult to interpret the results.
Britain, which has long championed the home vaccine, authorized the injection in late December, relying on the results of previous clinical tests. The European Union’s drug regulator did the same, but a month later.
EU officials said the delay resulted in part from a back-and-forth between regulators and AstraZeneca over the quality of the data.
And even after the vaccine was authorized, several European countries initially restricted it to younger people, citing the lack of sufficient data on its effectiveness in older people. This problem should be solved by the American trial, in which the elderly were better represented.
Neither European nor British regulators gave any indication on Tuesday that problems with AstraZeneca’s American data would have any impact on launches there. These agencies have relied on a separate set of non-American test data to authorize the vaccine.
“We are in contact with the company to address this additional information,” said the European Medicines Agency in a statement on Tuesday, “and the EMA will evaluate the data in question as soon as the company sends it to us.”
Matina Stevis-Gridneff contributed reporting from Brussels.